Author(s):
Hailye Birhane, Mojahidul Islam, Damen H/mariam, Vijender Singh
Email(s):
bhailye@gmail.com
DOI:
10.5958/0974-360X.2021.00266.3 
Address:
Hailye Birhane1*, Mojahidul Islam1, Damen H/mariam2, Vijender Singh1
1School of Pharmacy, Sharda University, Plot No. 32, 34, Knowledge Park III, Greater Noida, U. P. 201310, India.
2Addis Ababa University, College of Health Science, School of Public Health, Addis Ababa, Ethiopia.
*Corresponding Author
Published In:
Volume - 14,
Issue - 3,
Year - 2021
ABSTRACT:
Objective: To Characterize spontaneously reported pediatric adverse drug reactions (ADRs) in Ethiopia. Method: The detail of reported pediatric ADRs data to Ethiopian national Pharmacovigilance (PV) center during the 5year period (May/2014 to 2019) was collected. Data collection was done using the suspected ADRs reporting form and a retrospective analysis was done after excluding incomplete data’s. The data were analyzed in respect of age, sex, rate of reporting, suspected ADRs, suspected drugs, seriousness, onset and outcome. Result: Pediatric ADRs reporting rate was 0.9 per million children per year. A total of 218 reports containing 294 suspected drugs, 460 ADRs and 354 affected body systems (SOCs) were reported from government and private health facilities. Out of which, 53.6% were females. A majority, 201 (92.2%) and 166 (76%) reports were submitted by government health facilities and pharmacists respectively. >75% of ADRs affecting the skin, general disorders and nervous system. >75% of drugs associated with ADRs were anti-infective drugs 206 (70%) followed by nervous system drugs 20 (6.8%). Among anti-infective drugs, antibiotics, antiretroviral and ant-tuberculosis drugs represented 97% of drugs responsible for ADRs and 25% of ADRs were serious. Conclusion: Pediatric ADRs reporting rate was very low and public health program medicine safety monitoring is inadequate in Ethiopia. This suggests that the ADRs monitoring system was generally weak. Anti-infective drugs and nervous system drugs were responsible for the majority of ADRs and for all reported fatalities. The most common adverse reactions in pediatrics were skin disorders.
Cite this article:
Hailye Birhane, Mojahidul Islam, Damen H/mariam, Vijender Singh. Pharmacovigilance: Adverse Drug Reactions (ADRs) in Pediatric patients in Ethiopia. Retrospective Study. Research J. Pharm. and Tech 2021; 14(3):1499-1506. doi: 10.5958/0974-360X.2021.00266.3
Cite(Electronic):
Hailye Birhane, Mojahidul Islam, Damen H/mariam, Vijender Singh. Pharmacovigilance: Adverse Drug Reactions (ADRs) in Pediatric patients in Ethiopia. Retrospective Study. Research J. Pharm. and Tech 2021; 14(3):1499-1506. doi: 10.5958/0974-360X.2021.00266.3 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-3-55
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